Methods for increasing shelf-life of ophthalmic pharmaceutical compositions

Abstract

The present disclosure relates to methods for extending the shelf life of a sterile ophthalmic pharmaceutical composition.

What is claimed is: 
     
         1 . A method for extending the shelf life of a sterile, preservative-free, ophthalmic pharmaceutical composition, the method comprising:
 autoclaving a first phase composition consisting of prednisolone or a pharmaceutically acceptable salt thereof, sodium acetate, sodium chloride polyoxyethylene sorbitan monooleate, hydroxypropyl methylcellulose, optionally hydrochloric acid, optionally sodium hydroxide, and water;   autoclaving or sterile filtering a second phase composition consisting of moxifloxacin, bromfenac, sodium phosphate, sodium metabisulfite, edetate disodium, boric acid, sodium borate, optionally hydrochloric acid, optionally sodium hydroxide, and water; and   combining the first phase composition and the second phase composition, aseptically,   wherein the ophthalmic pharmaceutical composition has a shelf life that is at least 90 days when stored at room temperature.   
     
     
         2 . The method of  claim 1 , wherein the autoclaving temperature is about 121° C. 
     
     
         3 . The method of  claim 1 , wherein the autoclaving pressure is about 15 psi to about 18 psi. 
     
     
         4 . The method of  claim 1 , wherein the first phase composition is autoclaved for about 30 minutes. 
     
     
         5 . The method of  claim 1 , wherein the second phase composition is autoclaved for about 30 minutes. 
     
     
         6 . The method of  claim 1 , wherein the shelf life of the ophthalmic pharmaceutical composition is at least 120 days when stored at room temperature. 
     
     
         7 . The method of  claim 6 , wherein the shelf life of the ophthalmic pharmaceutical composition is at least 180 days when stored at room temperature. 
     
     
         8 . The method of  claim 7 , wherein the shelf life of the ophthalmic pharmaceutical composition is at least 240 days when stored at room temperature. 
     
     
         9 . The method of  claim 8 , wherein the shelf life of the ophthalmic pharmaceutical composition is at least 270 days when stored at room temperature. 
     
     
         10 . The method of  claim 9 , wherein the shelf life of the pharmaceutical composition is at least 300 days when stored at room temperature. 
     
     
         11 . The method of  claim 10 , wherein the shelf life of the ophthalmic pharmaceutical composition is at least 365 days when stored at room temperature. 
     
     
         12 . The method of  claim 1 , wherein the ophthalmic pharmaceutical composition has a pH of between about 7.5 to about 9.0. 
     
     
         13 . The method of  claim 12 , wherein the ophthalmic pharmaceutical composition has a pH of between about 8.3 to about 8.5.